实例探究 > Establishing Design Control Processes for Today and the Future

Establishing Design Control Processes for Today and the Future

公司规模
200-1,000
地区
  • America
国家
  • United States
产品
  • Arena
  • QAD ERP
技术栈
  • Product Realization Platform
  • ERP System
实施规模
  • Enterprise-wide Deployment
影响指标
  • Customer Satisfaction
  • Digital Expertise
  • Productivity Improvements
技术
  • 功能应用 - 企业资源规划系统 (ERP)
  • 功能应用 - 产品生命周期管理系统 (PLM)
适用行业
  • 医疗保健和医院
  • 生命科学
适用功能
  • 产品研发
  • 质量保证
服务
  • 系统集成
  • 培训
关于客户
Imagine a cancer treatment scenario where a medical device detects, analyzes, and treats multiple tumors in a single treatment. RefleXion is pursuing a valiant mission to impact the lives of millions of cancer patients around the world with the first biology-guided radiotherapy (BgRT) system. In support of the mission, RefleXion has chosen Arena as the system of record for design and quality controls. RefleXion Medical is on a fast-paced, high-growth path with its mission to provide better options for cancer patients worldwide. The company’s growth has been aggressive, even by startup standards, tripling the team in 18 months.
挑战
RefleXion Medical is on a fast-paced, high-growth path with its mission to provide better options for cancer patients worldwide. Innovation drives the team’s product development. At the same time, RefleXion adheres to the highest quality and compliance standards for life sciences companies. Almost from the beginning of product design, RefleXion knew they needed the support of a product realization platform that would grow with the team, the product, and their path through medical device compliance. The company’s growth has been aggressive, even by startup standards, tripling the team in 18 months. With fast team growth and continued product design progress, RefleXion needs everyone in sync.
解决方案
RefleXion began with Arena to manage parts and bills of materials (BOMs) and standard operating procedure (SOP) documentation rollout and then continued to utilize Arena for product revision control. The company uses Arena’s document, quality, training, and project management capabilities for product processes, including nonconformance reports (NCRs) and device history files (DHFs) organization. Arena is also integrated with the company’s QAD enterprise resource planning (ERP) system for purchasing processes. Summing up RefleXion’s choice, Dipali says: 'Arena is a powerful tool, optimized to control parts and BOMs, and additionally allows review and approval of design and quality system documents with integrated training. While other systems offer similar functionality, the ease of configuration and the validation quick start package made Arena the right choice for RefleXion.'
运营影响
  • Cycle-time reductions
  • Confidence in design control
  • Every single person at RefleXion uses Arena, ensuring everyone is in sync.
  • Arena allows review and approval of design and quality system documents with integrated training.
  • Arena is integrated with the company’s QAD ERP system for purchasing processes.
数量效益
  • Tripled the team in 18 months.

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